EP2827934B1 - Système et procédé pour coupler un tube à un manche de dispositif médical - Google Patents

Système et procédé pour coupler un tube à un manche de dispositif médical Download PDF

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Publication number
EP2827934B1
EP2827934B1 EP13734892.6A EP13734892A EP2827934B1 EP 2827934 B1 EP2827934 B1 EP 2827934B1 EP 13734892 A EP13734892 A EP 13734892A EP 2827934 B1 EP2827934 B1 EP 2827934B1
Authority
EP
European Patent Office
Prior art keywords
connector port
interior
exterior
medical device
extension tube
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Not-in-force
Application number
EP13734892.6A
Other languages
German (de)
English (en)
Other versions
EP2827934A2 (fr
Inventor
Patrick Senarith
James V. Kauphusman
Asim Syed
Terry Sterrett
Kirk Wu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
St Jude Medical Atrial Fibrillation Division Inc
Original Assignee
St Jude Medical Atrial Fibrillation Division Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by St Jude Medical Atrial Fibrillation Division Inc filed Critical St Jude Medical Atrial Fibrillation Division Inc
Publication of EP2827934A2 publication Critical patent/EP2827934A2/fr
Application granted granted Critical
Publication of EP2827934B1 publication Critical patent/EP2827934B1/fr
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0136—Handles therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2051—Electromagnetic tracking systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09116—Design of handles or shafts or gripping surfaces thereof for manipulating guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1094—Tube connectors; Tube couplings at least partly incompatible with standard connectors, e.g. to prevent fatal mistakes in connection

Definitions

  • the instant disclosure relates to medical devices, including handles for elongate medical devices.
  • elongate medical devices such as, for example, catheters and sheaths or introducers
  • catheters and sheaths or introducers When performing various therapeutic and/or diagnostic medical procedures on or in various anatomical structures of a patient's body, such as, for example, the heart.
  • Such devices generally include an elongate shaft having a proximal end portion, a distal end portion, a number of electrical and fluid elements, and a handle assembly disposed at the proximal end portion of the shaft.
  • the handle assembly In order to provide access to the electrical and fluid elements in the shaft, the handle assembly generally includes one or more connector ports through which one or more connectors may provide connections to fluid supplies, mapping and navigation systems, and the like.
  • a connector may move in a port, and the components on the interior of the handle to which the connector is coupled (such as, for example, a fluid lumen or an electrical wire) may twist or stretch.
  • This movement of a connector and/or interior components may have undesirable effects, such as leakage of irrigation fluid due to crimping of an internal fluid lumen and/or separation of a connector from its connector port.
  • US 4,791,912 A relates to an endoscope, comprising an insertion section, an operation section, a channel duct disposed in the insertion section, the channel duct having a distal end and a proximal end, a support tube located in the operation section and having a notch, a mouthpiece socket connected to the proximal end of the channel duct, a channel mouthpiece, one end of which is detachably connected to the mouthpiece socket and another end of which is formed with an opening, a cover member surrounding the periphery of the notch and having an opening through which the channel mouthpiece is inserted, and a support member fixed in the notch and having retaining means adapted to engage the mouthpiece socket.
  • WO 2011/140583 A1 discloses a catheter handle which includes a handle body having a proximal end and a distal end and a passage extending between the proximal end and the distal end, the handle body comprising a plurality of shell parts which can be at least partially separated from each other to access an interior of the handle body, a connector mounted at the proximal end of the handle body, and a strain relief arranged distally of the body, the strain relief and the connector being removably arranged relative to the handle body.
  • US 4,682,981 A discloses a medical device having an outer cylinder and an inner cylinder hub which has a hollow portion communicating with the interior of the outer cylinder and fixed to a proximal portion of the outer cylinder, wherein an inner cylinder is provided which can be detachably inserted into the outer cylinder through the hollow portion of the outer cylinder hub, wherein an inner cylinder hub is provided which has a hollow portion communicating with the interior of the inner cylinder, can be fitted within the outer cylinder hub, and is connected to a proximal portion of the inner cylinder, wherein means is arranged between the outer and inner cylinder hubs for preventing relative axial movement of the outer and inner cylinder hubs when the inner cylinder is inserted into the outer cylinder and the inner cylinder is fitted into the outer cylinder hub, and wherein means is arranged between the outer and inner cylinder hubs for preventing relative circumferential rotation of the outer and inner cylinder hubs.
  • the present invention provides an elongate medical device handle assembly according to claim 1 and a method for manufacturing a medical device handle assembly according to claim 8. Further developments of the present invention are set out in the dependent claims.
  • proximal and distal may be used throughout the specification with reference to a clinician manipulating one end of an instrument used to treat a patient.
  • proximal refers to the portion of the instrument closest to the clinician and the term “distal” refers to the portion located furthest from the clinician.
  • distal refers to the portion located furthest from the clinician.
  • spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein with respect to the illustrated embodiments.
  • surgical instruments may be used in many orientations and positions, and these terms are not intended to be limiting and absolute.
  • Figure 1 is a longitudinal cross-sectional view of an embodiment of an elongate medical device 10.
  • the medical device 10 may be one of many types known in the art such as, for example only, a catheter or a sheath.
  • the medical device will be referred to as a catheter 10, though it is not so limited.
  • the catheter 10 may include an elongate shaft 12 (only a portion of which is shown) and a handle assembly 14.
  • the handle assembly 14 may be used to guide the shaft 12 to a desired location within a patient to perform a desired procedure such as, for example, an ablation procedure, an electrophysiology (EP) mapping procedure, and/or a geometry mapping procedure.
  • the catheter 10 may be coupled to a mapping and navigation system (not shown). Exemplary mapping and navigation systems are illustrated and described in U.S. patent application no. 13/231,284 , which is hereby incorporated by reference in its entirety.
  • the shaft 12 may extend between a proximal end 16 and a distal end (not shown) and may include a number of features to enable the shaft to be guided to a particular location and to perform one or more procedures.
  • the shaft 12 may include one or more control elements (not shown), such as shape memory wires and/or pull wires.
  • the shaft 12 may include one or more sensors (not shown), such as electrodes and/or electromagnetic coils, that may be electrically coupled to one or more visualization, mapping, and navigation systems known in the art. Such sensors may also be used for mapping the geometry of one or more anatomical features, such as a chamber of the heart. Electrodes (not shown) may also be provided for collection of other data, such as EP data for creating an EP map of an organ, such as the heart. The same or additional electrodes may also be provided for therapeutic purposes, such as for the delivery of ablation energy.
  • the shaft 12 may also include a number of fluid features to, for example, irrigate an ablation tip to, e.g., minimize coagulum formation during delivery of ablation energy.
  • the shaft 12 may include one or more fluid lumens 18 extending from the handle assembly 14 to the distal tip of the shaft 12.
  • the shaft 12 may also include one or more fluid ports, manifolds, and other features (not shown) for directing irrigation fluid over or near the surface of one or more ablation electrodes. Examples of such irrigation features may be found in United States patent application publication no. 2008/0249522 A1 , which is hereby incorporated by reference as though set forth herein in its entirety.
  • the handle assembly 14 may include an outer body portion 20, a distal interior handle portion 22, and a proximal interior handle portion 24 (which may simply be referred to as the "proximal portion 24") collectively defining an interior 26 and having an exterior.
  • Two or more of the handle body portions 20, 22, 24 may move relative to one another to, for example, actuate one or more pull wires for deflecting or steering a portion, such as a distal portion, of the shaft.
  • distal interior handle portion 22 may move linearly in a longitudinal direction (e.g ., left and right on the page of Figure 1 ) with respect to outer body portion 20 and proximal interior handle portion 24. Examples of such steering features may be found in United States Patent No. 5,782,828 , which is hereby incorporated by reference as though set forth herein in its entirety.
  • the handle assembly 14 may include one or more features for connecting electrical elements in the shaft 12 (e.g., position sensors and mapping and therapy electrodes) to the systems and components outside the catheter that enable the operation of the electrical elements (e.g ., mapping and navigation systems, ablation generators).
  • At least one electrical wire 28 may extend through the interior 26 to provide a connection between the electrical elements in the shaft and the exterior systems.
  • the electrical wire 28 may be electrically coupled with an exterior electrical connection 30, which may be inserted into the proximal interior handle portion 24 through an electrical connector port 32.
  • the exterior electrical connection 30 may comprise materials and construction known in the art, and may be secured in the electrical connector port 32 through techniques known in the art, such as friction fit and adhesives, for example.
  • An embodiment of the electrical connector port 32 is shown in greater detail in Figures 3-12 .
  • the handle assembly 14 also includes features for connecting fluid elements in the shaft 12 (e.g., fluid lumens and irrigation ports) to fluid sources disposed outside the catheter.
  • the interior fluid tube or lumen 18 may extend though the interior 26 and may be fluidly coupled with a fluid lumen in the shaft 12 ( i.e., allowing fluid to flow therebetween) and may be fluidly coupled with and/or pass through an exterior fluid connector, which is an extension tube 34.
  • the extension tube 34 may comprise a polymer known in the art, such as polyurethane or PebaxTM, commercially available from Arkema, Inc.
  • the extension tube 34 may additionally comprise braiding or another structural support layer or material, as known in the art.
  • the extension tube 34 may be inserted into the proximal interior handle portion 24 through a fluid connector port 36 and may be secured within the fluid connector port 36 through friction fit, adhesives, as described in conjunction with Figures 2A-2C , or other techniques known in the art.
  • the adhesive may comprise a urethane-based adhesive, in an embodiment. Examples of urethane-based adhesives include PolycinTM and VoriteTM, though other adhesives, including urethane-based adhesives, may additionally or alternatively be used.
  • proximal interior handle portion 22 may comprise a polymer known in the art, such as polyoxymethylene (POM) sold under the trade name Delrin® and commercially available from E. I. du Pont de Nemours and Company.
  • POM polyoxymethylene
  • Figure 2A is an enlarged diagrammatic view of the coupling of an embodiment of the extension tube 34 with the fluid connector port 36.
  • the handle body portions such as the proximal portion 24
  • the fluid extension tube 34 may be secured in place with an adhesive 38, such as a urethane-based adhesive, as mentioned above. That is, a surface 42 of the fluid connector port 36 may be bonded to a surface 44 of the extension tube 34.
  • the fluid extension tube 34 may comprise, for example and without limitation, PebaxTM and/or another polymer and a braided layer, as noted above, and may proximally terminate in a luer connection 40. Coupling of the extension tube 34 and the fluid connector port 36 may be aided by a shape ( i.e., a polygonal shape) of the fluid connector port 36 and/or by a treatment process, as described below.
  • Figure 2B is a diagrammatic view of a second embodiment of a coupling of the extension tube 34 with the fluid connector port 36.
  • the extension tube 34 may be placed inside of a second tube 46.
  • the second tube 46 may comprise, for example, a shrink tube.
  • the extension tube 34 may be joined with the second tube 46 with additional adhesive 38, in an embodiment.
  • the second tube 46 may be joined to the fluid connector port 36.
  • the exterior of the second tube 46 may serve as the relevant surface ( i.e., instead of the surface of the extension tube 34 itself) for bonding the extension tube 34 with the fluid connector port 36 ( i.e., the surface to which a treatment process may be applied, as discussed in conjunction with Figure 13 ).
  • Figure 2C is a diagrammatic view of a third embodiment of a coupling of the extension tube 34 with the fluid connector port 36.
  • the proximal end of the extension tube 34 may be disposed inside of a third tube 48 and joined to the third tube 48 with additional adhesive 38.
  • the third tube 48 may comprise a shrink tube, in an embodiment.
  • Figures 3 and 4 are isometric views of a portion of an embodiment of the proximal portion 24, and Figures 5 and 6 are opposing end views of the proximal portion 24.
  • the proximal portion 24' may include a proximal exterior 50, a body 52 defining an interior 54, and a fluid connector port 36 and an electrical connector port 32 extending between the interior 54 and exterior 50.
  • the fluid connector port 36 may define, extend along, and be generally radially symmetric about an axis A
  • the electrical connection port 32 may define, extend along, and be generally radially symmetric about an axis B.
  • the electrical connector port 32 may comprise a cylindrical passageway through a portion of the body 52-that is, a cross-section of the passageway, taken transverse to the axis B, may be substantially circular. In the embodiment shown, the electrical connector port 32 is disposed on the proximal end of the proximal portion 24, and thus would be on the proximal end of the handle assembly 14 itself. In an embodiment, the electrical connector port 32 may taper from interior to exterior or from exterior to interior.
  • the fluid connector port 36 may comprise a polygonal passageway 56 through a portion of the body 52-that is, a cross-section of the passageway 56, taken transverse to the axis A, may be substantially polygonal.
  • the polygon may comprise a plurality of sides between convex and/or concave vertices.
  • the polygon may comprise alternating convex and concave vertices, so as to form a star pattern.
  • the polygonal portion 56 of the fluid connector port 36 may include any number of sides ( e.g., at least four (4), six (6), eight (8), or more sides) and any suitable convex and/or concave polygonal shapes, such as a rectangle, hexagon, octagon, or other shape. One or more sides of the polygon may be straight, as shown in Figures 3-6 , or arcuate, as shown in Figures 10-12 .
  • the polygonal portion 56 of the fluid connector port 36 may be tapered, in an embodiment, from interior to exterior or from exterior to interior.
  • the fluid connector port 36 may further comprise a circular portion 58 disposed on the exterior- i.e ., proximal-side of the polygonal portion 56.
  • the circular portion 58 also may be tapered from interior to exterior or from exterior to interior, as shown. Alternatively, the circular portion 58 may comprise a counterbore.
  • the shape of the fluid connector port 36 may be configured such that a mechanical interlock forms when the adhesive cures therein and around the portion of the extension tube 34 disposed within the fluid connector port 36.
  • the polygonal portion 56 of the fluid connector port 36 may provide more surface area for adhesive bonding than would a circular configuration, facilitating receipt of a fluid connector such as the extension tube 34 and allowing for a more secure coupling between the proximal portion 24 and a fluid connector such as the extension tube 34.
  • Figure 7 is an isometric view of another embodiment of the proximal interior handle portion 24'.
  • Figure 8 is a side view of the proximal interior handle portion 24'.
  • Figure 9 is an enlarged cross-sectional view of a portion of the proximal interior handle portion 24', with an embodiment of the extension tube 34' additionally shown in phantom.
  • Figure 10 is a cross-sectional view of proximal interior handle portion 24'.
  • Figured 11 and 12 are opposing end views of the proximal interior handle portion 24'.
  • the proximal interior handle portion 24' is substantially the same as the proximal interior handle portion 24 illustrated in Figures 3-6 , but the configuration of the fluid connector port 36' in Figures 7-12 is different from the fluid connector port 36 in Figures 3-6 .
  • the fluid connector port 36' may include portion 56' having a polygonal cross-section with arcuate sides.
  • the fluid connector port 36' may include a flared circular portion 58' on a proximal side of the port 36'.
  • adhesive may be used to secure a connector in the fluid connector port 36', and the adhesive may be applied to the flared circular portion 58' of the port so as to form a flange that prevents a distal force on the fluid extension tube 34, 34' along the axis A from pushing the tube 34, 34' into the interior of the handle.
  • the flared portion 58' of the fluid connector port 36' may, in an embodiment, include a cross-sectional shape that is substantially circular, as shown, or that is other than a circle.
  • an embodiment of the extension tube 34' inserted through the port 36' may include a flange 60 to prevent a proximal force on the extension tube 34' along the axis A from pulling the tube 34' out of the handle.
  • Such an extension tube 34' may also find use with the fluid connector port 36 shown in Figures 3-6 and other embodiments.
  • Figure 13 is a flow chart illustrating a portion of an exemplary method 64 of manufacturing a medical device handle assembly.
  • the method 64 along with other steps not detailed herein but known in the art, may be performed to manufacture an embodiment of the handle assembly 10 shown in Figure 1 .
  • the method 64 will therefore be described with reference to the handle assembly 10 and handle portion embodiments 24, 24' illustrated in Figures 1-12 . It should be understood, however, that the method is not limited to such handles and handle portions.
  • the method 64 may begin with a step 66 of constructing or otherwise providing a handle portion at least partially defining an interior of the handle and having an exterior.
  • the handle portion may include a connector port extending between the interior and the exterior and defining an axis that extends from the interior to the exterior.
  • the connector port may comprise a substantially polygonal cross-section taken transverse to the axis.
  • the handle portion may be or may comprise, in embodiments, proximal portion 24 or proximal portion 24'.
  • the configuration of the fluid connector ports 36, 36' may allow for a very strong mechanical interlock and thus may obviate the need for other steps or procedures for improving adhesive bonding, such as treating the fluid connector port 36 or extension tube 34, that may be necessary for other ports and connectors (such as known circular ports, for example). Accordingly, the fluid connector ports 36, 36' may allow for simpler manufacturing of a handle assembly than in known devices.
  • the method 64 may continue to two treatment steps 68, 70, if desired.
  • the treatment steps 68, 70 may be optional (i.e., one or both of the treatment steps 68, 70 may be omitted from some embodiments of the method 64).
  • the treatment steps 68, 70 may include a step 68 of treating a surface of the connector port of the handle portion and a step 70 of treating a connector.
  • proximal interior handle portion 22 may have a relatively low surface energy
  • adhesive bonding may be improved by treating surfaces of the interior proximal handle portion 24, 24' before applying adhesive.
  • a surface 40 of the fluid connector port 36, 36' and/or a surface 42 of the fluid extension tube 34, 34' may be treated to improve adhesion.
  • a plasma treatment and an abrasion treatment may be applied, in embodiments of the treatment steps 68, 70, in addition to other known treatment processes.
  • the surface energy of the adhesive must be less than that of the surface to which the adhesive is intended to bond.
  • one or more materials comprising the interior handle portion 24, 24' may have relatively low surface energies, making adhesive bonding difficult.
  • a plasma treatment process may be applied to the bonding surface (e.g ., surfaces 40, 42) to raise its surface energy to improve bonding by an adhesive.
  • the plasma treatment process may include placing the interior handle portion 22 (or the extension tube 34, 34' and any exterior layers of materials) in a plasma treatment chamber ( i.e ., between an anode plate and a cathode plate in the chamber).
  • An inert gas such as nitrogen, may be introduced into the chamber.
  • Energy may be delivered to the anode and cathode plates to cause the inert gas to ionize and form a plasma.
  • the plasma may be used to react with or energetically scrub debris on the treated surface.
  • the plasma may also be used to form functional surface groups.
  • the plasma treatment may occur at a relatively low temperature (e.g ., room temperature) and may leave little to no residue or debris on the treated surface.
  • the surface 40 of the fluid connector port 36, the surface 42 of the fluid extension tube, and/or other surfaces involved in bonding may be abrasion-treated.
  • an abrasion treatment process may involve the use of pneumatic energy to deliver abrasive media to the bonding surface(s).
  • the abrasion may remove debris from the treated surface as well as some of the material comprising the surface, increasing the surface area of the surface. By removing debris and increasing surface area, the surface energy of the surface may be increased, improving adhesion.
  • cleaning may be required following abrasion treatment to remove debris from the treated surface and adjacent surfaces.
  • an abrasion treatment process may include masking surfaces of the interior handle portion 24, 24' besides the surface 40 of the port 36, 36', masking portions of the surface 42 of the extension tube 34, 34' and/or other surfaces, and may further include a cleaning step following the treatment.
  • Plasma and/or abrasion treatment processes may also be applied to the electrical connector port 32 and/or the exterior electrical connection 30 during manufacturing. Any adhesive 38 applied may also be subjected to a curing process to improve adhesion.
  • the method 64 may continue to a step 72 of coupling the connector with the connector port.
  • the coupling step 72 may include, for example, inserting the connector into the connector port from the proximal or distal end of the connector port.
  • the coupling step 72 may also include, in embodiments, applying an adhesive to one or more surfaces of the connector port, the connector, and/or other intervening materials or layers.
  • the remainder of the handle assembly may be constructed according to known methods.
  • the design and construction of the handle assembly 14, and the proximal portions 24, 24' in particular, may lead to a more secure coupling between the fluid extension tube 34, 34' and the fluid connector port 36, 36' than in known designs.
  • the proximal portions 24, 24' may also allow for simpler manufacturing than known designs.
  • the polygonal cross-section of the fluid connector port 36, 36' provides ample surface area for adhesive to adhere and, in conjunction with cured or dried adhesive therein, forms a mechanical interlock that also prevents or resists rotation of the fluid extension tube 34, 34' within the port 36, 36'.
  • the use of a urethane-based adhesive may be more reliable than presently-used adhesives.
  • the circular portion 58, 58' may serve as a reservoir or well for adhesive to pool and harden in something of a fillet or flared shape such that linear movement, e.g ., in and out of the port 36, 36', may be prevented or resisted.
  • the various treating and curing processes that may be performed may also improve the strength of the bond between the fluid extension tube 34, 34' and the fluid connector port 36, 36'. As a result, the fluid extension tube 34, 34' may be securely held within the fluid connector port 36, 36' to prevent or resist twisting and stretching of components within the interior 26 of the handle assembly 14.
  • joinder references e.g., attached, coupled, connected, and the like
  • joinder references are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements.
  • joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the scope of the invention as defined in the appended claims.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Pulmonology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Surgical Instruments (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Claims (10)

  1. Ensemble manche de dispositif médical allongé (14) comprenant :
    un corps (20, 22, 24, 24') définissant un intérieur (26), un extérieur et un orifice de raccord (36, 36'), ledit orifice de raccord (36, 36') comprenant un passage ouvert s'étendant entre ledit intérieur (26) et ledit extérieur et définissant un axe (A) qui s'étend dudit intérieur (26) audit extérieur ; et
    un raccord (34, 34') s'étendant dudit intérieur audit extérieur à travers ledit orifice de raccord (36, 36'), dans lequel le raccord (34, 34') est un tube de rallonge, et dans lequel le tube de rallonge (34, 34') est fixé audit orifice de raccord (36, 36'),
    caractérisé en ce que ledit orifice de raccord (36, 36') comprend une première partie axiale (56, 56') ayant une première forme en section transversale considérée transversalement audit axe (A), et une seconde partie axiale (58, 58') ayant une seconde forme en section transversale considérée transversalement audit axe (A), dans lequel ladite première forme en section transversale est différente de ladite seconde forme en section transversale et dans lequel ladite première forme en section transversale est sensiblement polygonale et dans lequel ladite seconde forme en section transversale est sensiblement circulaire ou autre qu'un cercle.
  2. Ensemble manche de dispositif médical (14) selon la revendication 1, dans lequel ladite première forme en section transversale polygonale comprend au moins huit côtés.
  3. Ensemble manche de dispositif médical (14) selon la revendication 1 ou 2, comprenant un adhésif (38) configuré pour fixer ledit tube de rallonge (34, 34') à l'intérieur dudit orifice de raccord (36, 36'),
    dans lequel ledit adhésif (38) comprend de préférence un adhésif à base d'uréthane, et/ou
    dans lequel ledit adhésif (38) est de préférence durci.
  4. Ensemble manche de dispositif médical (14) selon la revendication 3, dans lequel ledit tube de rallonge (34, 34') est couplé à une lumière de fluide disposée dans ledit intérieur (26).
  5. Ensemble manche de dispositif médical (14) selon l'une quelconque des revendications précédentes,
    dans lequel ladite seconde partie axiale (58, 58') est située plus près dudit extérieur que ladite première partie axiale (56, 56'), et/ou
    dans lequel ladite seconde partie axiale (58, 58') comprend une partie évasée ou effilée.
  6. Ensemble manche de dispositif médical (14) selon l'une quelconque des revendications précédentes, dans lequel ladite première partie axiale (56, 56') comprend une pluralité de côtés entre une pluralité de sommets, dans lequel lesdits côtés sont incurvés, ou
    dans lequel ladite première partie axiale (56, 56') comprend une pluralité de côtés entre une pluralité de sommets, dans lequel lesdits côtés sont droits.
  7. Ensemble dispositif médical (14) selon l'une quelconque des revendications précédentes, dans lequel ladite première partie axiale (56, 56') comprend une forme en étoile.
  8. Procédé de fabrication d'un ensemble manche de dispositif médical comprenant :
    la fourniture d'une partie de manche pour ensemble manche de dispositif médical, la partie de manche définissant au moins partiellement un intérieur du manche et ayant un extérieur, la partie de manche comprenant un orifice de raccord s'étendant entre l'intérieur et l'extérieur et définissant un axe qui s'étend de l'intérieur à l'extérieur, dans lequel l'orifice de raccord comprend une première partie axiale définissant une section transversale sensiblement polygonale considérée transversalement audit axe et une seconde partie axiale définissant une ouverture sensiblement circulaire transversalement audit axe, dans lequel ledit orifice de raccord comprend en outre une partie ayant une section transversale circulaire considérée transversalement audit axe ; et
    le couplage d'un raccord audit orifice de raccord, dans lequel le raccord est un tube de rallonge et s'étend dudit intérieur audit extérieur à travers ledit orifice de raccord.
  9. Procédé selon la revendication 8, dans lequel ledit couplage comprend l'application d'un adhésif entre le tube de rallonge et l'orifice de raccord,
    dans lequel le procédé comprend en outre de préférence le traitement de l'orifice de raccord avant l'application de l'adhésif,
    dans lequel ledit traitement comprend de préférence un traitement par plasma ou un traitement par abrasion.
  10. Procédé selon la revendication 8 ou 9, dans lequel ledit tube de rallonge comprend un conduit de fluide s'étendant à travers ledit orifice de raccord le long dudit axe.
EP13734892.6A 2012-07-10 2013-06-18 Système et procédé pour coupler un tube à un manche de dispositif médical Not-in-force EP2827934B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261670081P 2012-07-10 2012-07-10
US13/840,196 US10039912B2 (en) 2012-07-10 2013-03-15 System and method for coupling a tube with a medical device handle
PCT/US2013/046368 WO2014011367A2 (fr) 2012-07-10 2013-06-18 Système et procédé pour coupler un tube à un manche de dispositif médical

Publications (2)

Publication Number Publication Date
EP2827934A2 EP2827934A2 (fr) 2015-01-28
EP2827934B1 true EP2827934B1 (fr) 2018-08-08

Family

ID=49914589

Family Applications (1)

Application Number Title Priority Date Filing Date
EP13734892.6A Not-in-force EP2827934B1 (fr) 2012-07-10 2013-06-18 Système et procédé pour coupler un tube à un manche de dispositif médical

Country Status (5)

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US (1) US10039912B2 (fr)
EP (1) EP2827934B1 (fr)
JP (1) JP6110941B2 (fr)
CN (1) CN104321104B (fr)
WO (1) WO2014011367A2 (fr)

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CN111359076B (zh) * 2020-03-16 2021-10-08 中国人民解放军陆军特色医学中心 一种便于操控的血管造影导管

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Also Published As

Publication number Publication date
WO2014011367A2 (fr) 2014-01-16
US10039912B2 (en) 2018-08-07
CN104321104A (zh) 2015-01-28
US20140018749A1 (en) 2014-01-16
JP6110941B2 (ja) 2017-04-05
EP2827934A2 (fr) 2015-01-28
CN104321104B (zh) 2016-11-02
WO2014011367A3 (fr) 2014-05-08
JP2015522358A (ja) 2015-08-06

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